Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Port wine stains are red birthmarks that without treatment persist for a lifetime. They are frequently found on the face and can be conspicuous and disfiguring, negatively impacting social interactions for these patients. Treating Port wine stains is difficult. The standard of care is to use laser treatment, but over 80% of patients fail to completely clear despite multiple treatments. The growth of additional blood vessels (angiogenesis) following the Laser treatment is likely an important factor in why these lesions persist despite therapy.

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Key information

Conditions

Port Wine Stain Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Port-Wine Stain Skin Abnormalities Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beckman Laser Institute Medical and Surgical Cilnic

Irvine, California, 92612, United States

About this study

Imiquimod is a topical cream that affects the immune response and has been noted to inhibit blood vessel formation. It has been used to successfully treat other vascular growths such as hemangiomas. The research can use imiquimod cream 5% cream apply to port wine stains after laser therapy to improve lightening of port wine stains. The imiquimod 5% cream cream apply to Port wine stains everyday for 8 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of Port Wine Stain birthmark
Male and female subjects of any age who are in good health.
Fitzpatrick skin type I-VI

Exclusion criteria

Pregnant or lactating
History of cutaneous photosensitivity
History of hypersensitivity to imiquimod 5% cream or any of its components
History of photodermatoses

Treatment and study plan

Imiquimod

Drug

Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Other names: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser

Placebo

Other

Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Other names: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser

Primary outcomes

Change From Baseline in a* and E at 8 Weeks

Time frame: 8 weeks baseline

Change in a* and ΔE is a way to quantify PWS treatment outcome: a* is the erythema of the vascular lesions and varies from +60 for green to -60 for red with a value of +9.28 for Normal Skin. Higher a* values indicates a greater reduction in erythema hence better treatment outcome. ΔE detects all three dimensions of colorspace (L*a*b*) and represents the difference in color between normal and PWS skin. Range of ΔE is 0 to 100. Higher values indicates improved treatment efficacy by greater skin color improvement.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

Beckman Laser Institute University of California Irvine

Registry information

Acronym: Aldara

Important dates

Study start: 2006
Primary completion: 2012
Study completion: 2012
First posted: Jan 3, 2008
Registry last updated: Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed